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GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

Primary Purpose

Coronary Artery Disease (CAD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ticagrelor
Acetylsalicylic Acid
Clopidogrel
Sponsored by
ECRI bv
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease (CAD) focused on measuring CAD, ACS, All comers, DAPT, PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-"All comer" patients

  1. Age ≥18 years;
  2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);
  3. Able to provide informed consent and willing to participate in 2 year follow- up period.

Exclusion Criteria:

  1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
  2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
  3. Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);
  4. Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  5. Need for chronic oral anti-coagulation therapy;
  6. Active major bleeding or major surgery within the last 30 days;
  7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
  8. Known stroke (any type) within the last 30 days;
  9. Known pregnancy at time of randomisation;
  10. Female who is breastfeeding at time of randomisation;
  11. Currently participating in another trial and not yet at its primary endpoint.

Sites / Locations

  • Research centre Brisbane, 6101
  • Research centre Melbourne, 6104
  • Research centre Melbourne, 6105
  • Research centre Graz, 4305
  • Rsearch centre Innsbruck, 4303
  • Research centre Linz, 4304
  • Research centre Vienna, 4301
  • Research centre Vienna, 4302
  • Research centre Aalst, 3201
  • Research centre Aalst, 3206
  • Research centre Bonheiden, 3204
  • Research centre Charleroi, 3202
  • Research centre Genk, 3205
  • Research centre Hasselt, 3203
  • Research centre Rio de Janeiro, 5503
  • Research centre Rio de Janeiro, 5504
  • Research centre Sao Paulo, 5501
  • Research centre Sao Paulo, 5502
  • Research centre Uberlândia, 5505
  • Research centre Burgas, 9902
  • Research centre Plovdiv, 9905
  • Research centre Sofia, 9901
  • Research centre Sofia, 9903
  • Research centre Sofia, 9904
  • Research centre Sofia, 9907
  • Research centre Sofia, 9908
  • Research centre Varna, 9906
  • Research centre Newmarket, 1003
  • Research centre Quebec, 1001
  • Research centre Copenhagen, 4501
  • Research centre Roskilde, 4503
  • Research centre Aix en Provence, 3311
  • Research centre Caen, 3308
  • Research centre Caen, 3309
  • Research centre Clermont-Ferrand, 3303
  • Research centre Dijon, 3313
  • Research centre Grenoble, 3312
  • Research centre Lyon, 3316
  • Research centre Nancy, 3314
  • Research centre Paris, 3301
  • Research centre Paris, 3305
  • Research centre Rouen, 3307
  • Research centre Saint Etienne, 3310
  • Research centre Toulouse, 3302
  • Research centre Bad Krozingen, 4904
  • Research centre Bad Nauheim, 4902
  • Research centre Berlin, 4918
  • Research centre Bonn, 4911
  • Research centre Dresden, 4908
  • Research centre Essen, 4903
  • Research centre Fulda, 4905
  • Research centre Giessen 4901
  • Research centre Göttingen, 4907
  • Research centre Landshut, 4909
  • Research centre Lubeck, 4917
  • Research centre Mainz, 4910
  • Research centre Mannheim, 4912
  • Research centre Mönchengladbach, 4915
  • Research centre Neuss, 4916
  • Research centre Tubingen, 4914
  • Research centre Villingen - Schwenningen, 4919
  • Research centre Balatonfüred, 3608
  • Research centre Budapest, 3602
  • Research centre Budapest, 3603
  • Research centre Debrecen, 3607
  • Research centre Gyula, 3606
  • Research centre Nyíregyháza, 3605
  • Research centre Pécs, 3604
  • Research centre szeged, 3601
  • Research centre Arezzo, 3902
  • Research centre Brescia, 3912
  • Research centre Ferrara, 3905
  • Research centre Milano, 3901
  • Research centre Pavia, 3903
  • Research centre Terni, 3909
  • Research centre Alkmaar, 3106
  • OLVG Research centre Amsterdam, 3104
  • UMCG Groningen, 3108
  • Research centre Leeuwarden, 3102
  • Research centre Nieuwegein, 3107
  • Research centre Nijmegen, 3105
  • EMC Rotterdam, 3101
  • Maasstad Rotterdam, 3103
  • Research centre Tilburg, 3109
  • Research centre Chrzanow, 4802
  • Research centre Dabrowa Gornicza, 4801
  • Research centre Kedzierzyn-Kozle, 4805
  • Research centre Krakov, 4807
  • Research centre Mielec, 4809
  • Research centre Nysa, 4808
  • Research centre Ustroń, 4803
  • Research centre Gaia, 3501
  • Research centre Lisbon, 3503
  • Research centre Lisbon, 3504
  • Research centre Lisbon, 3505
  • Research centre Singapore, 6501
  • Research centre Singapore, 6502
  • Research centre Barcelona, 3401
  • Research centre Barcelona, 3403
  • Research centre Barcelona, 3405
  • Research centre Huelva, 3408
  • Research centre Madrid 3410
  • Research centre Madrid, 3402
  • Research centre Madrid, 3407
  • Research centre Madrid, 3409
  • Research centre Vigo, 3404
  • Research centre Bern, 4106
  • Research centre Bern, 4107
  • Research centre Geneva, 4101
  • Research centre Lausanne, 4104
  • Research centre Liestal, 4108
  • Research centre Lugano, 4105
  • Research centre Belfast, 4420
  • Research Centre Belfast, 4423
  • Research centre Blackburn, 4404
  • Research centre Blackpool, 4408
  • Research centre Bournemouth, 4418
  • Research centre Brighton, 4405
  • Research centre Cambridge, 4417
  • Research centre Cardiff, 4402
  • Research centre Glasgow, 4407
  • Research centre Leicester, 4421
  • Research centre Liverpool, 4001
  • Research centre Manchester, 4403
  • Research centre Manchester, 4406
  • Research centre Newcastle, 4413
  • Research centre Rhyl, 4414
  • Research centre Southampton, 4415
  • Research centre Stevenage, 4412
  • Research centre Wolverhampton, 4422

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental treatment strategy

Reference treatment strategy

Arm Description

All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy. Dosage and frequency: Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)

Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy. Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy. Dosage and frequency: Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd

Outcomes

Primary Outcome Measures

Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.

Secondary Outcome Measures

Number of Participants With All-cause Mortality
Number of Participants With Myocardial Infarction
Number of Participants With New Q-wave Myocardial Infarction
Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded
Number of Participants With a Stroke
Number of Participants With a Myocardial Revascularisation
Number of Participants With a Definite Stent Thrombosis
Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint. Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with: Type 3a: Overt bleeding + Hb drop of 3 to < 5 g/dL (provided Hb drop is related to bleed) Any transfusion with overt bleeding Type 3b: Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed) Cardiac tamponade Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid) Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal) Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision. Type 5: Fatal bleeding Type 5a: • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation

Full Information

First Posted
February 12, 2013
Last Updated
March 13, 2022
Sponsor
ECRI bv
Collaborators
Biosensors International, AstraZeneca, The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT01813435
Brief Title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Official Title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
November 9, 2015 (Actual)
Study Completion Date
April 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECRI bv
Collaborators
Biosensors International, AstraZeneca, The Medicines Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications. There are two medication strategies: Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely
Detailed Description
The study objective is to determine in all-comers patients undergoing percutaneous coronary intervention (PCI) under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave myocardial infarction (MI) compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy. The study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy. Randomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)). All patients will be followed for a period of 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
CAD, ACS, All comers, DAPT, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15991 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental treatment strategy
Arm Type
Experimental
Arm Description
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy. Dosage and frequency: Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Arm Title
Reference treatment strategy
Arm Type
Active Comparator
Arm Description
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy. Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy. Dosage and frequency: Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique
Intervention Description
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid
Other Intervention Name(s)
Aspirin, B01AC06
Intervention Description
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix, B01AC04
Intervention Description
Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy. Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy
Primary Outcome Measure Information:
Title
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Description
Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Number of Participants With All-cause Mortality
Time Frame
2-year
Title
Number of Participants With Myocardial Infarction
Time Frame
2 year
Title
Number of Participants With New Q-wave Myocardial Infarction
Time Frame
2-year
Title
Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
Description
shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded
Time Frame
2-year
Title
Number of Participants With a Stroke
Time Frame
2 year
Title
Number of Participants With a Myocardial Revascularisation
Time Frame
2 year
Title
Number of Participants With a Definite Stent Thrombosis
Time Frame
2 year
Title
Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
Description
BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint. Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with: Type 3a: Overt bleeding + Hb drop of 3 to < 5 g/dL (provided Hb drop is related to bleed) Any transfusion with overt bleeding Type 3b: Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed) Cardiac tamponade Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid) Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal) Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision. Type 5: Fatal bleeding Type 5a: • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -"All comer" patients Age ≥18 years; Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length); Able to provide informed consent and willing to participate in 2 year follow- up period. Exclusion Criteria: Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus; Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor; Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN); Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period; Need for chronic oral anti-coagulation therapy; Active major bleeding or major surgery within the last 30 days; Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm; Known stroke (any type) within the last 30 days; Known pregnancy at time of randomisation; Female who is breastfeeding at time of randomisation; Currently participating in another trial and not yet at its primary endpoint.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest Spitzer, MD
Organizational Affiliation
European Cardiovascular Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, Prof. MD
Organizational Affiliation
Inselspital, University Hospital Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research centre Brisbane, 6101
City
Brisbane
Country
Australia
Facility Name
Research centre Melbourne, 6104
City
Melbourne
Country
Australia
Facility Name
Research centre Melbourne, 6105
City
Melbourne
Country
Australia
Facility Name
Research centre Graz, 4305
City
Graz
Country
Austria
Facility Name
Rsearch centre Innsbruck, 4303
City
Innsbruck
Country
Austria
Facility Name
Research centre Linz, 4304
City
Linz
Country
Austria
Facility Name
Research centre Vienna, 4301
City
Vienna
Country
Austria
Facility Name
Research centre Vienna, 4302
City
Vienna
Country
Austria
Facility Name
Research centre Aalst, 3201
City
Aalst
Country
Belgium
Facility Name
Research centre Aalst, 3206
City
Aalst
Country
Belgium
Facility Name
Research centre Bonheiden, 3204
City
Bonheiden
Country
Belgium
Facility Name
Research centre Charleroi, 3202
City
Charleroi
Country
Belgium
Facility Name
Research centre Genk, 3205
City
Genk
Country
Belgium
Facility Name
Research centre Hasselt, 3203
City
Hasselt
Country
Belgium
Facility Name
Research centre Rio de Janeiro, 5503
City
Rio de Janeiro
Country
Brazil
Facility Name
Research centre Rio de Janeiro, 5504
City
Rio de Janeiro
Country
Brazil
Facility Name
Research centre Sao Paulo, 5501
City
Sao Paulo
Country
Brazil
Facility Name
Research centre Sao Paulo, 5502
City
Sao Paulo
Country
Brazil
Facility Name
Research centre Uberlândia, 5505
City
Uberlândia
Country
Brazil
Facility Name
Research centre Burgas, 9902
City
Burgas
Country
Bulgaria
Facility Name
Research centre Plovdiv, 9905
City
Plovdiv
Country
Bulgaria
Facility Name
Research centre Sofia, 9901
City
Sofia
Country
Bulgaria
Facility Name
Research centre Sofia, 9903
City
Sofia
Country
Bulgaria
Facility Name
Research centre Sofia, 9904
City
Sofia
Country
Bulgaria
Facility Name
Research centre Sofia, 9907
City
Sofia
Country
Bulgaria
Facility Name
Research centre Sofia, 9908
City
Sofia
Country
Bulgaria
Facility Name
Research centre Varna, 9906
City
Varna
Country
Bulgaria
Facility Name
Research centre Newmarket, 1003
City
Newmarket
Country
Canada
Facility Name
Research centre Quebec, 1001
City
Quebec
Country
Canada
Facility Name
Research centre Copenhagen, 4501
City
Copenhagen
Country
Denmark
Facility Name
Research centre Roskilde, 4503
City
Roskilde
Country
Denmark
Facility Name
Research centre Aix en Provence, 3311
City
Aix en Provence
Country
France
Facility Name
Research centre Caen, 3308
City
Caen
Country
France
Facility Name
Research centre Caen, 3309
City
Caen
Country
France
Facility Name
Research centre Clermont-Ferrand, 3303
City
Clermont-Ferrand
Country
France
Facility Name
Research centre Dijon, 3313
City
Dijon
Country
France
Facility Name
Research centre Grenoble, 3312
City
Grenoble Cedex
Country
France
Facility Name
Research centre Lyon, 3316
City
Lyon
Country
France
Facility Name
Research centre Nancy, 3314
City
Nancy
Country
France
Facility Name
Research centre Paris, 3301
City
Paris
Country
France
Facility Name
Research centre Paris, 3305
City
Paris
Country
France
Facility Name
Research centre Rouen, 3307
City
Rouen
Country
France
Facility Name
Research centre Saint Etienne, 3310
City
Saint Etienne
Country
France
Facility Name
Research centre Toulouse, 3302
City
Toulouse
Country
France
Facility Name
Research centre Bad Krozingen, 4904
City
Bad Krozingen
Country
Germany
Facility Name
Research centre Bad Nauheim, 4902
City
Bad Nauheim
Country
Germany
Facility Name
Research centre Berlin, 4918
City
Berlin
Country
Germany
Facility Name
Research centre Bonn, 4911
City
Bonn
Country
Germany
Facility Name
Research centre Dresden, 4908
City
Dresden
Country
Germany
Facility Name
Research centre Essen, 4903
City
Essen
Country
Germany
Facility Name
Research centre Fulda, 4905
City
Fulda
Country
Germany
Facility Name
Research centre Giessen 4901
City
Giessen
Country
Germany
Facility Name
Research centre Göttingen, 4907
City
Göttingen
Country
Germany
Facility Name
Research centre Landshut, 4909
City
Landshut
Country
Germany
Facility Name
Research centre Lubeck, 4917
City
Lubeck
Country
Germany
Facility Name
Research centre Mainz, 4910
City
Mainz
Country
Germany
Facility Name
Research centre Mannheim, 4912
City
Mannheim
Country
Germany
Facility Name
Research centre Mönchengladbach, 4915
City
Mönchengladbach
Country
Germany
Facility Name
Research centre Neuss, 4916
City
Neuss
Country
Germany
Facility Name
Research centre Tubingen, 4914
City
Tubingen
Country
Germany
Facility Name
Research centre Villingen - Schwenningen, 4919
City
Villingen - Schwenningen
Country
Germany
Facility Name
Research centre Balatonfüred, 3608
City
Balatonfüred
Country
Hungary
Facility Name
Research centre Budapest, 3602
City
Budapest
Country
Hungary
Facility Name
Research centre Budapest, 3603
City
Budapest
Country
Hungary
Facility Name
Research centre Debrecen, 3607
City
Debrecen
Country
Hungary
Facility Name
Research centre Gyula, 3606
City
Gyula
Country
Hungary
Facility Name
Research centre Nyíregyháza, 3605
City
Nyíregyháza
Country
Hungary
Facility Name
Research centre Pécs, 3604
City
Pécs
Country
Hungary
Facility Name
Research centre szeged, 3601
City
Szeged
Country
Hungary
Facility Name
Research centre Arezzo, 3902
City
Arezzo
Country
Italy
Facility Name
Research centre Brescia, 3912
City
Brescia
Country
Italy
Facility Name
Research centre Ferrara, 3905
City
Ferrara
Country
Italy
Facility Name
Research centre Milano, 3901
City
Milano
Country
Italy
Facility Name
Research centre Pavia, 3903
City
Pavia
Country
Italy
Facility Name
Research centre Terni, 3909
City
Terni
Country
Italy
Facility Name
Research centre Alkmaar, 3106
City
Alkmaar
Country
Netherlands
Facility Name
OLVG Research centre Amsterdam, 3104
City
Amsterdam
Country
Netherlands
Facility Name
UMCG Groningen, 3108
City
Groningen
Country
Netherlands
Facility Name
Research centre Leeuwarden, 3102
City
Leeuwarden
Country
Netherlands
Facility Name
Research centre Nieuwegein, 3107
City
Nieuwegein
Country
Netherlands
Facility Name
Research centre Nijmegen, 3105
City
Nijmegen
Country
Netherlands
Facility Name
EMC Rotterdam, 3101
City
Rotterdam
Country
Netherlands
Facility Name
Maasstad Rotterdam, 3103
City
Rotterdam
Country
Netherlands
Facility Name
Research centre Tilburg, 3109
City
Tilburg
Country
Netherlands
Facility Name
Research centre Chrzanow, 4802
City
Chrzanow
Country
Poland
Facility Name
Research centre Dabrowa Gornicza, 4801
City
Dabrowa Gornicza
Country
Poland
Facility Name
Research centre Kedzierzyn-Kozle, 4805
City
Kedzierzyn-Kozle
Country
Poland
Facility Name
Research centre Krakov, 4807
City
Krakov
Country
Poland
Facility Name
Research centre Mielec, 4809
City
Mielec
Country
Poland
Facility Name
Research centre Nysa, 4808
City
Nysa
Country
Poland
Facility Name
Research centre Ustroń, 4803
City
Ustroń
Country
Poland
Facility Name
Research centre Gaia, 3501
City
Gaia
Country
Portugal
Facility Name
Research centre Lisbon, 3503
City
Lisbon
Country
Portugal
Facility Name
Research centre Lisbon, 3504
City
Lisbon
Country
Portugal
Facility Name
Research centre Lisbon, 3505
City
Lisbon
Country
Portugal
Facility Name
Research centre Singapore, 6501
City
Singapore
Country
Singapore
Facility Name
Research centre Singapore, 6502
City
Singapore
Country
Singapore
Facility Name
Research centre Barcelona, 3401
City
Barcelona
Country
Spain
Facility Name
Research centre Barcelona, 3403
City
Barcelona
Country
Spain
Facility Name
Research centre Barcelona, 3405
City
Barcelona
Country
Spain
Facility Name
Research centre Huelva, 3408
City
Huelva
Country
Spain
Facility Name
Research centre Madrid 3410
City
Madrid
Country
Spain
Facility Name
Research centre Madrid, 3402
City
Madrid
Country
Spain
Facility Name
Research centre Madrid, 3407
City
Madrid
Country
Spain
Facility Name
Research centre Madrid, 3409
City
Madrid
Country
Spain
Facility Name
Research centre Vigo, 3404
City
Vigo
Country
Spain
Facility Name
Research centre Bern, 4106
City
Bern
Country
Switzerland
Facility Name
Research centre Bern, 4107
City
Bern
Country
Switzerland
Facility Name
Research centre Geneva, 4101
City
Geneva
Country
Switzerland
Facility Name
Research centre Lausanne, 4104
City
Lausanne
Country
Switzerland
Facility Name
Research centre Liestal, 4108
City
Liestal
Country
Switzerland
Facility Name
Research centre Lugano, 4105
City
Lugano
Country
Switzerland
Facility Name
Research centre Belfast, 4420
City
Belfast
Country
United Kingdom
Facility Name
Research Centre Belfast, 4423
City
Belfast
Country
United Kingdom
Facility Name
Research centre Blackburn, 4404
City
Blackburn
Country
United Kingdom
Facility Name
Research centre Blackpool, 4408
City
Blackpool
Country
United Kingdom
Facility Name
Research centre Bournemouth, 4418
City
Bournemouth
Country
United Kingdom
Facility Name
Research centre Brighton, 4405
City
Brighton
Country
United Kingdom
Facility Name
Research centre Cambridge, 4417
City
Cambridge
Country
United Kingdom
Facility Name
Research centre Cardiff, 4402
City
Cardiff
Country
United Kingdom
Facility Name
Research centre Glasgow, 4407
City
Glasgow
Country
United Kingdom
Facility Name
Research centre Leicester, 4421
City
Leicester
Country
United Kingdom
Facility Name
Research centre Liverpool, 4001
City
Liverpool
Country
United Kingdom
Facility Name
Research centre Manchester, 4403
City
Manchester
Country
United Kingdom
Facility Name
Research centre Manchester, 4406
City
Manchester
Country
United Kingdom
Facility Name
Research centre Newcastle, 4413
City
Newcastle
Country
United Kingdom
Facility Name
Research centre Rhyl, 4414
City
Rhyl
Country
United Kingdom
Facility Name
Research centre Southampton, 4415
City
Southampton
Country
United Kingdom
Facility Name
Research centre Stevenage, 4412
City
Stevenage
Country
United Kingdom
Facility Name
Research centre Wolverhampton, 4422
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30166073
Citation
Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.
Results Reference
background
PubMed Identifier
35260381
Citation
Ono M, Hara H, Kawashima H, Gao C, Wang R, Wykrzykowska JJ, Piek JJ, Garg S, Hamm C, Steg PG, Valgimigli M, Windecker S, Vranckx P, Onuma Y, Serruys PW. Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial. EuroIntervention. 2022 Aug 5;18(5):e377-e388. doi: 10.4244/EIJ-D-21-00870.
Results Reference
derived
PubMed Identifier
35229616
Citation
Gragnano F, Zwahlen M, Vranckx P, Heg D, Schmidlin K, Hamm C, Steg PG, Gargiulo G, McFadden EP, Onuma Y, Chichareon P, Benit E, Mollmann H, Janssens L, Leonardi S, Zurakowski A, Arrivi A, Van Geuns RJ, Huber K, Slagboom T, Calabro P, Serruys PW, Juni P, Valgimigli M, Windecker S; GLOBAL LEADERS Investigators [Link]. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2022 May 17;11(10):e024291. doi: 10.1161/JAHA.121.024291. Epub 2022 Mar 1.
Results Reference
derived
PubMed Identifier
35041147
Citation
Westra J, Eftekhari A, Renkens M, Mejia-Renteria H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH. Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up. Int J Cardiovasc Imaging. 2022 Jan 18. doi: 10.1007/s10554-022-02522-1. Online ahead of print.
Results Reference
derived
PubMed Identifier
34533034
Citation
Vranckx P, Valgimigli M, Odutayo A, Serruys PW, Hamm C, Steg PG, Heg D, Mc Fadden EP, Onuma Y, Benit E, Janssens L, Diletti R, Ferrario M, Huber K, Raber L, Windecker S, Juni P; GLOBAL LEADERS Investigators. Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.
Results Reference
derived
PubMed Identifier
33066794
Citation
Gao C, Tomaniak M, Takahashi K, Kawashima H, Wang R, Hara H, Ono M, Montalescot G, Garg S, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, van Geuns RJ, Hamm C, Steg PG, Onuma Y, Angiolillo DJ, Serruys PW. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial. Cardiovasc Diabetol. 2020 Oct 16;19(1):179. doi: 10.1186/s12933-020-01153-x.
Results Reference
derived
PubMed Identifier
33065080
Citation
Kawashima H, Tomaniak M, Ono M, Wang R, Hara H, Gao C, Takahashi K, Sharif F, Thury A, Suryapranata H, Walsh S, Cotton J, Carrie D, Sabate M, Steinwender C, Leibundgut G, Wykrzykowska J, de Winter RJ, Garg S, Hamm C, Steg PG, Juni P, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW. Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS). Am J Cardiol. 2021 Jan 1;138:1-10. doi: 10.1016/j.amjcard.2020.09.057. Epub 2020 Oct 13.
Results Reference
derived
PubMed Identifier
32941872
Citation
Gao C, Takahashi K, Garg S, Hara H, Wang R, Kawashima H, Ono M, Montalescot G, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, Hamm C, Steg PG, Storey R, van Geuns RJ, Tao L, Onuma Y, Serruys PW. Regional variation in patients and outcomes in the GLOBAL LEADERS trial. Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.
Results Reference
derived
PubMed Identifier
32838554
Citation
Hara H, Takahashi K, Kogame N, Tomaniak M, Kerkmeijer LSM, Ono M, Kawashima H, Wang R, Gao C, Wykrzykowska JJ, de Winter RJ, Neumann FJ, Plante S, Lemos Neto PA, Garg S, Juni P, Vranckx P, Windecker S, Valgimigli M, Hamm C, Steg PG, Onuma Y, Serruys PW. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2020 Sep;13(9):e009177. doi: 10.1161/CIRCINTERVENTIONS.120.009177. Epub 2020 Aug 25.
Results Reference
derived
PubMed Identifier
32762446
Citation
Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Juni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, Serruys PW; GLOBAL LEADERS Trial Investigators. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. Circ Cardiovasc Qual Outcomes. 2020 Aug;13(8):e006660. doi: 10.1161/CIRCOUTCOMES.120.006660. Epub 2020 Jul 30.
Results Reference
derived
PubMed Identifier
32006156
Citation
Ono M, Chichareon P, Tomaniak M, Kawashima H, Takahashi K, Kogame N, Modolo R, Hara H, Gao C, Wang R, Walsh S, Suryapranata H, da Silva PC, Cotton J, Koning R, Akin I, Rensing BJWM, Garg S, Wykrzykowska JJ, Piek JJ, Juni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial. Clin Res Cardiol. 2020 Sep;109(9):1125-1139. doi: 10.1007/s00392-020-01604-1. Epub 2020 Jan 31.
Results Reference
derived
PubMed Identifier
31925529
Citation
Tomaniak M, Chichareon P, Klimczak-Tomaniak D, Takahashi K, Kogame N, Modolo R, Wang R, Ono M, Hara H, Gao C, Kawashima H, Rademaker-Havinga T, Garg S, Curzen N, Haude M, Kochman J, Gori T, Montalescot G, Angiolillo DJ, Capodanno D, Storey RF, Hamm C, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW, Anderson R. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clin Res Cardiol. 2020 Jul;109(7):930-943. doi: 10.1007/s00392-019-01586-9. Epub 2020 Jan 10.
Results Reference
derived
PubMed Identifier
31876907
Citation
Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernandez Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, Serruys PW; GLOBAL LEADERS Study Investigators. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):222-230. doi: 10.1093/ehjcvp/pvz052.
Results Reference
derived
PubMed Identifier
31845894
Citation
Tomaniak M, Chichareon P, Modolo R, Takahashi K, Chang CC, Kogame N, Spitzer E, Buszman PE, van Geuns RM, Valkov V, Steinwender C, Geisler T, Prokopczuk J, Sabate M, Zmudka K, Rademaker-Havinga T, Tijssen JGP, Juni P, Hamm C, Steg PG, Onuma Y, Vranckx P, Valgimigli M, Windecker S, Baber U, Anderson R, Dominici M, Serruys PW. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial. EuroIntervention. 2020 Apr 3;15(18):e1605-e1614. doi: 10.4244/EIJ-D-19-00699.
Results Reference
derived
PubMed Identifier
31693078
Citation
Chichareon P, Modolo R, Kerkmeijer L, Tomaniak M, Kogame N, Takahashi K, Chang CC, Komiyama H, Moccetti T, Talwar S, Colombo A, Maillard L, Barlis P, Wykrzykowska J, Piek JJ, Garg S, Hamm C, Steg PG, Juni P, Valgimigli M, Windecker S, Onuma Y, Mehran R, Serruys PW. Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):21-29. doi: 10.1001/jamacardio.2019.4296.
Results Reference
derived
PubMed Identifier
31623758
Citation
Takahashi K, Serruys PW, Chichareon P, Chang CC, Tomaniak M, Modolo R, Kogame N, Magro M, Chowdhary S, Eitel I, Zweiker R, Ong P, Ottesen MM, Tijssen JGP, Wykrzykowska JJ, de Winter RJ, Garg S, Stoll HP, Hamm C, Steg PG, Onuma Y, Valgimigli M, Vranckx P, Carrie D, Windecker S. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI. J Am Coll Cardiol. 2019 Oct 22;74(16):2015-2027. doi: 10.1016/j.jacc.2019.08.997.
Results Reference
derived
PubMed Identifier
31557763
Citation
Tomaniak M, Chichareon P, Onuma Y, Deliargyris EN, Takahashi K, Kogame N, Modolo R, Chang CC, Rademaker-Havinga T, Storey RF, Dangas GD, Bhatt DL, Angiolillo DJ, Hamm C, Valgimigli M, Windecker S, Steg PG, Vranckx P, Serruys PW; GLOBAL LEADERS Trial Investigators. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial. JAMA Cardiol. 2019 Nov 1;4(11):1092-1101. doi: 10.1001/jamacardio.2019.3355.
Results Reference
derived
PubMed Identifier
30888959
Citation
Serruys PW, Tomaniak M, Chichareon P, Modolo R, Kogame N, Takahashi K, Chang CC, Spitzer E, Walsh SJ, Adlam D, Hildick-Smith D, Edes I, van de Harst P, Krackhardt F, Tijssen JGP, Rademaker-Havinga T, Garg S, Steg PG, Hamm C, Juni P, Vranckx P, Onuma Y, Verheugt FWA. Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial. EuroIntervention. 2019 Dec 20;15(12):e1090-e1098. doi: 10.4244/EIJ-D-19-00202.
Results Reference
derived
PubMed Identifier
30852547
Citation
Leonardi S, Franzone A, Piccolo R, McFadden E, Vranckx P, Serruys P, Benit E, Liebetrau C, Janssens L, Ferrario M, Zurakowski A, van Geuns RJ, Dominici M, Huber K, Slagboom T, Buszman P, Bolognese L, Tumscitz C, Bryniarski K, Aminian A, Vrolix M, Petrov I, Garg S, Naber C, Prokopczuk J, Hamm C, Steg G, Heg D, Juni P, Windecker S, Valgimigli M. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). BMJ Open. 2019 Mar 9;9(3):e026053. doi: 10.1136/bmjopen-2018-026053.
Results Reference
derived
Links:
URL
http://dx.doi.org/10.1016/S0140-6736(18)31858-0
Description
Pubmed Identifier 30166073

Learn more about this trial

GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

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